Sickle Cell Disease
Conditions
Keywords
Zinc, All-cause infections
Brief summary
A randomized double-blinded placebo-controlled trial of zinc to reduce the incidence of severe or invasive infections in Ugandan children with sickle cell anemia (SCA)
Detailed description
The study will be a randomized, placebo-controlled, double blind clinical trial in which 100 Ugandan children 1.00-4.99 years of age with SCA will receive zinc (20 mg oral dispersible tablet daily) or placebo (identical to zinc in appearance) for 6 months. The primary study outcome will be incidence of infection (all causes).
Interventions
DRUGzinc sulfate
Dispersible (20 mg) tablet
DRUGPlacebo
Dispersible tablet
Sponsors
Indiana University
Global Health Uganda LTD
Makerere University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Double-blinded placebo-controlled trial
Intervention model description
A randomized double-blinded placebo-controlled trial
Eligibility
Sex/Gender
ALL
Age
12 Months to 59 Months
Healthy volunteers
No
Inclusion criteria
* Documented sickle cell anemia (HbSS supported by hemoglobin electrophoresis) * Age range of 1.00-4.99 years, inclusive, at the time of enrollment * Weight at least 5.0 kg at the time of enrollment * Willingness to comply with all study-related treatments, evaluations, and follow-up * Children whose parents or guardians give full written informed consent
Exclusion criteria
* Known other chronic medical condition (e.g., HIV, malignancy, active clinical tuberculosis) * Severe malnutrition determined by impaired growth parameters as defined by WHO (weight for length/height or height for age z-score \<-3, using WHO growth standards) * Absolute neutropenia (absolute neutrophil count \<500)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of all-cause infections in the zinc vs. placebo groups | 6 months | Will assess the difference in the incidence of all cause infection between the Placebo arm and the experimental arm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of infections requiring hospitalization | 6 months | Incidence of Advance events greater or equal to grade 3 |
| Incidence of adverse events requiring discontinuation of study drug | 6 months | Incidence of Zinc related Advance events |
| Incidence of stroke or death | 6 months | Incidence of death and stroke |
Countries
Uganda
Contacts
PRINCIPAL_INVESTIGATORChandy C John, MD
Indiana University
Outcome results
None listed